NDC 63323-960

Tigecycline

Tigecycline

Tigecycline is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Tigecycline.

Product ID63323-960_b21bfa63-6c2f-4728-8b1a-1ae56246c0c7
NDC63323-960
Product TypeHuman Prescription Drug
Proprietary NameTigecycline
Generic NameTigecycline
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2016-12-01
Marketing CategoryNDA / NDA
Application NumberNDA205645
Labeler NameFresenius Kabi USA, LLC
Substance NameTIGECYCLINE
Active Ingredient Strength50 mg/5mL
Pharm ClassesTetracycline-class Antibacterial [EPC],Tetracyclines [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63323-960-10

10 VIAL, SINGLE-DOSE in 1 CARTON (63323-960-10) > 5 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2016-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-960-10 [63323096010]

Tigecycline INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA205645
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-12-01

Drug Details

Active Ingredients

IngredientStrength
TIGECYCLINE50 mg/5mL

OpenFDA Data

SPL SET ID:acf5dbe5-ca75-4300-816f-b3f4625f6e7d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 581531
  • Pharmacological Class

    • Tetracycline-class Antibacterial [EPC]
    • Tetracyclines [CS]

    NDC Crossover Matching brand name "Tigecycline" or generic name "Tigecycline"

    NDCBrand NameGeneric Name
    0781-3481TigecyclineTigecycline
    16729-364TIGECYCLINETIGECYCLINE
    55150-228TigecyclineTigecycline
    60505-6098TigecyclineTIGECYCLINE
    63323-960TigecyclineTigecycline
    70121-1647TigecyclineTigecycline
    70594-035TigecyclineTigecycline
    71288-019TigecyclineTigecycline
    0008-4990TygacilTIGECYCLINE
    0008-4994TygacilTIGECYCLINE

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